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Controlled-Level EVERolimus in Acute Coronary Syndrome (CLEVER-ACS) - A phase II, randomized, double-blind, multi-center, placebo-controlled trial.
Klingenberg, Roland; Stähli, Barbara E; Heg, Dik; Denegri, Andrea; Manka, Robert; Kapos, Ioannis; von Eckardstein, Arnold; Carballo, David; Hamm, Christian W; Vietheer, Julia; Rolf, Andreas; Landmesser, Ulf; Mach, François; Moccetti, Tiziano; Jung, Christian; Kelm, Malte; Münzel, Thomas; Pedrazzini, Giovanni; Räber, Lorenz; Windecker, Stephan; Matter, Christian M; Ruschitzka, Frank; Lüscher, Thomas F.
  • Klingenberg R; Department of Cardiology, University Heart Center, University Hospital Zurich, Switzerland; Department of Cardiology, Kerckhoff Heart and Thorax Center, and Campus of the Justus Liebig University of Giessen, Germany; DZHK (German Center for Cardiovascular Research), partner site Rhine-Main, Bad Nauh
  • Stähli BE; Department of Cardiology, University Heart Center, University Hospital Zurich, Switzerland.
  • Heg D; Clinical Trial Unit, Social and Preventive Medicine, University of Bern, Switzerland.
  • Denegri A; Department of Cardiology, University Heart Center, University Hospital Zurich, Switzerland.
  • Manka R; Department of Cardiology, University Heart Center, University Hospital Zurich, Switzerland.
  • Kapos I; Department of Cardiology, University Heart Center, University Hospital Zurich, Switzerland.
  • von Eckardstein A; Department of Clinical Chemistry, University Hospital Zurich, Switzerland.
  • Carballo D; Department of Cardiology, Hopitaux Universitaires de Geneve, Geneva, Switzerland.
  • Hamm CW; Department of Cardiology, Kerckhoff Heart and Thorax Center, and Campus of the Justus Liebig University of Giessen, Germany; DZHK (German Center for Cardiovascular Research), partner site Rhine-Main, Bad Nauheim, Germany.
  • Vietheer J; Department of Cardiology, Kerckhoff Heart and Thorax Center, and Campus of the Justus Liebig University of Giessen, Germany; DZHK (German Center for Cardiovascular Research), partner site Rhine-Main, Bad Nauheim, Germany.
  • Rolf A; Department of Cardiology, Kerckhoff Heart and Thorax Center, and Campus of the Justus Liebig University of Giessen, Germany; DZHK (German Center for Cardiovascular Research), partner site Rhine-Main, Bad Nauheim, Germany.
  • Landmesser U; Department of Cardiology, University Heart Center, University Hospital Zurich, Switzerland; Department of Cardiology, Charité - University Medicine, , Berlin, Germany.
  • Mach F; Department of Cardiology, Hopitaux Universitaires de Geneve, Geneva, Switzerland.
  • Moccetti T; Department of Cardiology, Cardiocentro Ticino, Lugano, Switzerland.
  • Jung C; Division of Cardiology, Pulmonary Diseases and Vascular Medicine, University Hospital of Duesseldorf, Duesseldorf, Germany.
  • Kelm M; Division of Cardiology, Pulmonary Diseases and Vascular Medicine, University Hospital of Duesseldorf, Duesseldorf, Germany.
  • Münzel T; Department of Cardiology, University Hospital Mainz, Mainz, Germany.
  • Pedrazzini G; Department of Cardiology, Cardiocentro Ticino, Lugano, Switzerland.
  • Räber L; Department of Cardiology, Bern University Hospital, Inselspital, Bern, Switzerland.
  • Windecker S; Department of Cardiology, Bern University Hospital, Inselspital, Bern, Switzerland.
  • Matter CM; Department of Cardiology, University Heart Center, University Hospital Zurich, Switzerland; Center for Molecular Cardiology, University of Zurich, Schlieren, Switzerland.
  • Ruschitzka F; Department of Cardiology, University Heart Center, University Hospital Zurich, Switzerland.
  • Lüscher TF; Department of Cardiology, Bern University Hospital, Inselspital, Bern, Switzerland; Imperial College, National Heart and Lung Institute and Royal Brompton and Harefield Hospitals, Heart Division London, U.K.. Electronic address: cardio@tomluescher.ch.
Am Heart J ; 247: 33-41, 2022 05.
Article in English | MEDLINE | ID: covidwho-1652480
ABSTRACT

BACKGROUND:

Activation of inflammatory pathways during acute myocardial infarction contributes to infarct size and left ventricular (LV) remodeling. The present prospective randomized clinical trial was designed to test the efficacy and safety of broad-spectrum anti-inflammatory therapy with a mammalian target of rapamycin (mTOR) inhibitor to reduce infarct size.

DESIGN:

Controlled-Level EVERolimus in Acute Coronary Syndrome (CLEVER-ACS, clinicaltrials.gov NCT01529554) is a phase II randomized, double-blind, multi-center, placebo-controlled trial on the effects of a 5-day course of oral everolimus on infarct size, LV remodeling, and inflammation in patients with acute ST-elevation myocardial infarction (STEMI). Within 5 days of successful primary percutaneous coronary intervention (pPCI), patients are randomly assigned to everolimus (first 3 days 7.5 mg every day; days 4 and 5 5.0 mg every day) or placebo, respectively. The primary efficacy outcome is the change from baseline (defined as 12 hours to 5 days after pPCI) to 30-day follow-up in myocardial infarct size as measured by cardiac magnetic resonance imaging (CMRI). Secondary endpoints comprise corresponding changes in cardiac and inflammatory biomarkers as well as microvascular obstruction and LV volumes assessed by CMRI. Clinical events, laboratory parameters, and blood cell counts are reported as safety endpoints at 30 days.

CONCLUSION:

The CLEVER-ACS trial tests the hypothesis whether mTOR inhibition using everolimus at the time of an acute STEMI affects LV infarct size following successful pPCI.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Acute Coronary Syndrome / Anterior Wall Myocardial Infarction / Percutaneous Coronary Intervention / ST Elevation Myocardial Infarction / Myocardial Infarction Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Am Heart J Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Acute Coronary Syndrome / Anterior Wall Myocardial Infarction / Percutaneous Coronary Intervention / ST Elevation Myocardial Infarction / Myocardial Infarction Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Am Heart J Year: 2022 Document Type: Article